Abstract：Objective To observe the toxic reaction of high dose Jianweixiaoshi Tablets(only for children)to SD rats,and to provide the basis for the safe use of medicine in children.Methods A total of 60 SD rats aged 21 days were divided into the high-dose Jianweixiaoshi Tablets for children group(high-dose group)and solvent control group(control group)by alternating group according to body weight,with 30 rats in each group and half male and half female.The high-dose group was given 10 g/kg Jianweixiaoshi Tablets,and the solvent control group was given the same amount of pure water once a day for 4 weeks.After administration,40 rats were dissected and sampled,and the remaining 20 rats were dissected and sampled after 2-week recovery period.The changes of general condition,body weight,food intake,individual growth,sexual development,blood routine,blood biochemical,blood coagulation function,immune function,organ coefficient and histopathology were detected.Results After convalescence,there was no significant difference in food intake,body weight,development of bone,genitalia and immune system between the two groups(P＞0.05).The organ coefficients of liver,spleen and kidney in the high-dose group were higher than those in control group,the differences were statistically significant(P＜0.05).At the end of the administration,platelet overaccumulation and activated partial thromboplastin time of male rats in high-dose group were lower than those in control group,and triglyceride(TG),low density lipoprotein cholesterol(LDL-C)were higher than those in control group,the differences were statistically significant(P＜0.05).The erythrocyte overstock,aspartate transaminase,LDL-C and fasting blood glucose(GLU)of female rats in the high-dose group were higher than those in the control group,alanine transaminase and the percentage of lymphocytes was lower than that in the control group,the differences were statistically significant(P＜0.05).At the end of the recovery period,the number of platelets,TG and fibrinogen in male rats in the high-dose group were higher than those in control group,while the total bile acid(TBA)and fasting blood glucose in the highdose group were lower than those in control group,the differences were statistically significant(P＜0.05).The glutamyltranspeptidase and TG of female rats in high-dose group were lower than those in control group,while TBA was higher than those in control group,the differences were statistically significant(P＜0.05).At the end of the administration and the end of the recovery period,there was no statistical significance in the pathological scores of each organ between the high-dose group and the control group(P＞0.05).Conclusion After 4 weeks of intragastric administration of 10 g/kg Jianweixiaoshi Tablets(only for children)in SD rats,the blood routine,blood biochemical and coagulation function indexes of SD rats were slightly affected,but most of the indexes could be restored to normal level after the recovery period,and the pathological results of the organs did not show substantial damage.The non-toxic dose of Jianweixiaoshi Tablets(only for children)is not less than 10 g/kg,equivalent to 50 times of the clinical dose.
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